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    DRUG:

    lacnotuzumab (MCS110)

    i
    Other names: MCS110, MCS 110, MCS-110
    Company:
    Novartis
    Drug class:
    CSF-1 inhibitor
    Related drugs:
    4ms
    MCS110 With BRAF/MEK Inhibition in Patients With Melanoma (clinicaltrials.gov)
    P1/2; Active, not recruiting --> Completed | N=43 --> 6 | Trial completion date: Sep 2025 --> Sep 2023 | Trial primary completion date: Sep 2024 --> Sep 2023
    Trial completion date • Trial primary completion date • Enrollment change • Trial completion
    |
    OncoPanel™ Assay
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • lacnotuzumab (MCS110)
    6ms
    Phase Ib/II Study of Lacnotuzumab in Combination with Spartalizumab in Patients with Advanced Malignancies. (PubMed, J Immunother Precis Oncol)
    However, gating criteria for efficacy were not met for expansion beyond 80 patients in phase II and the sponsor did not continue development of the combination of spartalizumab and lacnotuzumab for oncology indications. The potential signal of activity in pancreatic cancer should be further explored.
    P1/2 data • Journal • Combination therapy • Metastases
    |
    CSF1 (Colony stimulating factor 1)
    |
    spartalizumab (PDR001) • lacnotuzumab (MCS110)
    over1year
    Updates on the Treatment of Tenosynovial Giant Cell Tumor. (PubMed, Hematol Oncol Stem Cell Ther)
    Pexidartinib is the first CSF-1 receptor inhibitor approved for the treatment of TGCT. Here, we discuss various available treatment strategies and ongoing investigations and trials targeting diffuse TGCT, which include nilotinib, lacnotuzumab, cabiralizumab, vimseltinib, and emactuzumab.
    Review • Journal
    |
    CSF1R overexpression
    |
    Tasigna (nilotinib) • Turalio (pexidartinib) • lacnotuzumab (MCS110) • cabiralizumab (BMS-986227) • emactuzumab (RG7155) • vimseltinib (DCC-3014)
    over1year
    A phase I/II study of MCS110 with BRAF/MEK inhibition in patients with melanoma after progression on BRAF/MEK inhibition. (PubMed, Invest New Drugs)
    MCS110 in combination with dabrafenib and trametinib was reasonably well tolerated in a small melanoma population. One response was observed in this small sample of patients suggesting this combination might be worthy of further exploration.
    P1/2 data • Clinical Trial,Phase I • Clinical Trial,Phase II • Journal • IO biomarker
    |
    CSF1 (Colony stimulating factor 1)
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • lacnotuzumab (MCS110)
    over1year
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=64, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; This was a sponsor decision and was not a consequence of any safety concern
    Trial termination • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    almost2years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=64, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2022 --> Feb 2023 | Trial primary completion date: Oct 2022 --> Feb 2023
    Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    over2years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=64, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2022 --> Oct 2022 | Trial primary completion date: Jun 2022 --> Oct 2022
    Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    almost3years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=64, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=220 --> 64 | Trial completion date: Jan 2022 --> Jun 2022 | Trial primary completion date: Jan 2022 --> Jun 2022
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    3years
    A Randomized Phase II Study of Anti-CSF-1 Monoclonal Antibody Lacnotuzumab (MCS110) Combined with Gemcitabine and Carboplatin in Advanced Triple Negative Breast Cancer. (PubMed, Clin Cancer Res)
    Despite successful target engagement and anticipated pharmacokinetic profile, lacnotuzumab+gem-carbo showed comparable antitumor activity to gem-carbo alone, with slightly poorer tolerability. However, the data presented in this manuscript would be informative for future studies testing agents targeting the CSF-1-CSF-1R pathway in TNBC.
    Clinical • P2 data • Journal
    |
    CSF1 (Colony stimulating factor 1) • CSF1R (Colony stimulating factor 1 receptor)
    |
    carboplatin • gemcitabine • lacnotuzumab (MCS110)
    over3years
    [VIRTUAL] On-target peripheral and tumor immune microenvironment modulation in patients treated with lacnotuzumab (anti-CSF1, MCS110) + spartalizumab (AACR 2021)
    Flow cytometric, circulating total CSF1 in plasma and gene expression profiling results demonstrated that targeting CSF-1 with lacnotuzumab in the periphery and tumor microenvironment leads to decrease in monocytes and reduced expression of macrophage associated genes in patients with advanced cancers. Unfortunately, in the heavily pretreated patient populations studied in this trial, only a limited clinical efficacy was demonstrated.
    Clinical • Late-breaking abstract • PD(L)-1 Biomarker • IO biomarker
    |
    CSF1 (Colony stimulating factor 1) • CSF1R (Colony stimulating factor 1 receptor)
    |
    spartalizumab (PDR001) • lacnotuzumab (MCS110)
    over4years
    Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P2, N=50, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Jul 2020 --> Mar 2020 | Trial primary completion date: Jul 2020 --> Mar 2020
    Clinical • Trial completion • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER negative • PGR negative
    |
    carboplatin • gemcitabine • lacnotuzumab (MCS110)
    over4years
    Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2020 --> Jul 2020 | Trial primary completion date: Dec 2019 --> Jul 2020
    Clinical • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER negative • PGR negative
    |
    carboplatin • gemcitabine • lacnotuzumab (MCS110)
    almost5years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=220, Recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2020 --> Jan 2022 | Trial primary completion date: Oct 2020 --> Jan 2022
    Clinical • Trial completion date • Trial primary completion date • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)